MDEC meeting 2008/1, 28 March 2008

Medical Device Evaluation Committee

Meeting report

The 2008/1 (17th) meeting of the Medical Device Evaluation Committee (MDEC) was held on 28 March 2008. The main points of discussion included:

• an application by William Cook Australia for the provision of a conformity assessment certificate for the Surgisis Biodesign recto-vaginal fistula plug for implantation to reinforce soft tissue in the repair of recto-vaginal fistulas, and the anal fistula plug for implantation to reinforce soft tissue where a rolled configuration is required for the repair of anorectal fistulas.
• an application by Johnson & Johnson Medical Pty Ltd T/A Depuy Australia for the provision of a conformity assessment certificate for the DuraForm dural graft implant for use in cranial and spinal procedures where the repair or the substitution of the patient's dura mater is required.
• consideration of the activity reports from the MDEC Subcommittees and Expert Advisory Groups.

The 2008/2 MDEC meeting is proposed for 13 June 2008.

Summary of key resolutions

NOTE: This summary has been prepared to provide rapid advice of the Resolutions made by the Medical Device Evaluation Committee (MDEC) at its recent meeting. It should not be assumed that recommendations made to the TGA represent the decisions of the TGA.

Device registrations

MDEC resolved that the following medical device applications should be approved, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the TGA.  These recommendations for approval may be subject to specific conditions.

Top of page